Marketing authorisation application for Erbitux submitted in Australia

Alphapharm, the Australian pharmaceuticals subsidiary of Merck KgaA, of Germany, has filed a marketing authorisation application with the Therapeutic Goods Administration (TGA) for Erbitux (cetuximab) for the indication of metastatic colorectal cancer. Alphapharm is seeking approval of cetuximab as a monotherapy and in combination with the standard chemotherapy irinotecan. As Alphapharm has applied for priority evaluation status, the company could receive authority approval by the end of 2004.

Merck KGaA licensed the right to market cetuximab outside of the US and Canada and the co-exclusive right to market cetuximab in Japan from ImClone Systems in 1998. In Europe, it filed marketing authorisation applications in June 2003 with EMEA and with Swissmedic for Erbitux, both for the indication of metastatic colorectal cancer. If successful, Merck could bring the cancer drug to market in Switzerland by the end of 2003, as the Swiss authority has determined that cetuximab is suitable for an accelerated registration procedure. Marketing authorisation across the EU is expected in 2004.

In the US, ImClone Systems is developing Erbitux in partnership with Bristol-Myers Squibb, and filed its Biologics License Application to the FDA in August 2003. The application was granted priority review, and the six-month review is expected to be completed by 13 February, 2004.